The primary reason for outsourcing preclinical research to a contract research organization (CRO) tends to be consolidation of infrastructure and lowering of fixed operating costs. According to a study conducted by The Tufts Center for the Study of Drug Development (Tufts CSDD), sponsors primarily make the decision to outsource because they believe the CRO is more cost-efficient and time-efficient than internal teams and they want to take advantage of the efficiency and capacity potential that these external players can offer. The study also showed that a sponsor’s primary criterion for selecting a CRO is its reputation to deliver on these cost-savings capacities.
The preclinical CRO is therefore under immense pressure to conduct studies and deliver results in a cost-effective and efficient way. Ideally, the facility will have the ability to spread overhead costs, including expert staff and equipment, over a large number of preclinical studies from different clients. But there are several factors that may influence their ability to do just that including: variables related to their own infrastructure, capacity and capability across each unique study and client. Challenges surface when the CRO is spread too thin and can no longer provide individualized focus on the services they provide. When this happens, quality of service falls short and so there is a careful balance for the CRO between taking on the right amount of work and maintaining the highest possible quality of work; but one constant remains: reputation is always on the line.
Common challenges that can arise for the preclinical CRO include:
Both the sponsor and the CRO are responsible for clearly establishing what the study goals are and what the scope of work entails. An experienced CRO will be able to efficiently navigate through the planning stages and will ensure that all staff roles and responsibilities are outlined in advance of proceeding with the study. In addition, projected costs should be explicitly discussed and agreed upon and a clear plan of action must be put in place for any deviations from the proposed budget. For example, in the case that there are Protocol Amendments affecting the study design after a budget is agreed upon, all parties should discuss the best path forward and approve any such changes. The capable CRO will attempt to offer cost-saving solutions to offset the additional costs when possible.
Sponsors will sometimes feel that their project is not being prioritized appropriately by their selected CRO. This is most often the case when there is inadequate equipment and/or staff on site to handle the specific needs of that client. Again, finding the balance between taking on sufficient work to be cost-effective and giving the appropriate attention to detail required by each project can be a challenge for the CRO. When overextended in this capacity, the experienced CRO will have relationships already in place allowing for seamless outsourcing. Outsourcing certain parts of a study to a reputable partner, rather than risk quality and reputation is a wise choice.
When challenges arise and deadlines are looming, the overworked CRO staff may want to put their heads down and try to push through the remaining work. But this is, in fact, the moment to be the most upfront about what is happening. Mistakes are made when things are rushed and the client will not appreciate being left in the dark. Scheduling weekly, consistent updates is essential to give the sponsor a sense of how things are progressing and where problems are likely to arise. This will save money and time in the long run as circumventing potential hurdles is far more efficient than backtracking. It will also help maintain a positive and direct relationship with the client that will ultimately reflect in their assessment of the outsourcing experience.
If you are a busy CRO and find that one or more of these challenges is infringing on the quality of work that you are able to deliver within budget, consider relieving some of the tension and outsourcing specific aspects of the work. You will save money and most importantly, your reputation for reliably delivering high quality results.
No budget for hiring more staff? Outsource histopathology and you may save money!
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